Ambulation performance in chronic stroke patients using an implanted drop foot stimulator

Phase 4

Completed

Conditions: central motor neuron lesion
10007963

Registration Number: NL-OMON32078

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

* age ><= 18 years;
* first ever supratentorial stroke with persistent neurological deficit
* post-stroke time between 6 and 24 months;
* Diagnosis and stroke severity
* BARTHEL INDEX * 15
*
* clinically diagnosed central paresis of the leg;
* drop foot, i.e. inability to achieve a normal heel strike during walking
* balance and gait-related criteria: subject is an outdoor walker:
* Berg Balance score 48/56;
* Rivermead mobility index 11/15.
* strength MRC grade * 3 at entry into the study
* no injury to peroneal nerves and sciatic nerve
* ( EMG to exclude peripheral nerve lesion,
* trial stimulation to evaluate dorsiflexion and eversion of the foot)
.

Exclusion Criteria

* pacemaker
* any medical condition that would exclude the use of a surgical procedure or anaesthetic
* pregnancy
* inability to read or understand Dutch or receptive aphasia?
* no informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measures:<br /><br>* Gait parameters: walking speed, gait symmetry, gait width, foot<br /><br>placement,cadence,gait fluency,<br /><br>* Two minute walking test (Brooks 2001, Datta 1996)<br /><br>* Functional gait performance: - outdoor circuit with different surface<br /><br>textures (Kölgen et al., 2002),<br /><br>indoor participation circuit (Hemmen et al., 2007; Stevens et al., 2006; Ilmer<br /><br>et al., 2007)<br /><br>- Family Qol & Stroke specific utlities.(see attachment)<br /><br>- Generic quality of life: SF-36 (vd Zee et al., 1993)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures:<br /><br>* * Functional health status: Functional Independence Measure (FIM) (Kidd et<br /><br>al., 1995)<br /><br>* Anxiety and depression: HADS (Spinhoven et al., 1997)<br /><br>Cognitive functioning: MMSE (Jackson et al., 2007)<br /><br>* Functional health status,<br /><br>. Functional independence measure (FIM)<br /><br>* Credibility/expectancy questionnaire (CEQ) (Devilly & Borkovec, 2000)</p><br>